Breaking Diagnostic Barriers
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Employment Opportunities

Careers

Mesa Biotech strives to deliver the next generation of reliable molecular diagnostic tests. The key to our success is our team of dedicated and talented employees, employees that are driven to deliver novel, quality diagnostic products. Explore the careers available at Mesa Biotech below:

Available Positions

Full Time, Industrial R&D Molecular Biology Postdoc, 2-year Interim

R&D Technician

Scientist I-II, R&D

Quality & Regulatory Affairs Director

 

Title: Full Time, Industrial R&D Molecular Biology Postdoc, 2-year Interim

Location: San Diego, California, USA

Overview: The Industrial R&D Molecular Biology Postdoc, 2-year Interim will be an integral part of the research, as well as the product development teams.  This position will work closely with other engineers and biochemists in the development of the next generation, affordable, in vitro, molecular diagnostic, point-of-care devices and instrumentation for human (especially Infectious diseases such as SARS, Influenza, RSV, HIV, Dengue etc.), animal and plant disease applications.

 

Duties:

  • The design and development of new in vitro molecular diagnostic nucleic acid amplification and detection assays suitable for infectious disease and other human molecular diagnostic purposes using MTI’s new diagnostic platform.
  • The development of proper clinical and environment sample collection and nucleic acid procedure suitable for human nasal, throat, skin swabs and blood specimen.
  • The concurrent assay testing, optimization and validation in the context of engineering of diagnostic products and instrumentation, easing the transition from research and development into a manufacturing setting.
  • The development of intellectual properties of new molecular diagnostics assays in the context of MTIDx platform. Assist with the patent applications when applicable.
  • Collaboration with academic, industrial and government collaborators to support the development of MTIDx-based diagnostic especially human infectious disease diagnostic products.
  • Assist with project related technical proposal, contract writing and presentation as applicable.
  • Flexible and versatile with programmatic tasks necessary to meet project milestones and deliverables.
  • Travels related to the programmatic activities and company business (no more than 20% travel is anticipated)

 

Skills:

  • Demonstrated experience with PCR, real time PCR methods
  • Bioinformatic primer/probe design experience and hand-on experience of PCR assay development, optimization and clinical validation
  • Hands on experience with handling BSL-2/3 human pathogens, especially human infectious diseases, e.g. Influenza, SARS, Dengue Viruses, HIV
  • Experience of clinical sample validation and statistical analysis
  • Excellent presentation and written skills
  • Excellent team working and communication skill

 

Desired Skills:

  • Familiarity with phylogenetic, nucleic acid primer/probe design software
  • Clinical validation and familiarity with bio-statistical analysis is highly desirable
  • Enzyme kinetic and/or structural analysis is highly desirable
  • BSL-2 laboratory oversight skills
  • Experience with writing SOP is highly desirable

 

Education: 

  • A minimum of a Ph.D. in Biology, Molecular Biology, Cell Biology

 

 

Title: R&D Technician

 

Location: San Diego, CA

 

Overview: A motivated and independent molecular biology research scientist is sought to support the development of point of care molecular diagnostic kits in a demanding, fast-paced environment.  The successful candidate will work closely with other scientists to develop and validate sample preparation methods as well as aid in the optimization of amplification methodologies. Additional duties may include device testing and verification as well as aiding in the QC process. Attention to detail and the ability to write and follow SOPs is critical. The ideal candidate will have demonstrated biochemistry and molecular biology expertise and experience with PCR and Real Time-PCR technology. Experience working with infectious agents in a BSL-2 environment is desired.

Duties:

  • RT-PCR, quantitative real time PCR methods
  • Hands-on experience with PCR assay development and optimization
  • Isolation of nucleic acids from a variety of sources
  • Ability to work in a multidisciplinary team environment
  • Good communication skills
  • Excellent team working and communication skill

Skills:

  • Hands on experience with handling BSL-2 pathogens
  • Clinical validation experience is desirable

Requirements: 

  • At least a Bachelor’s in Biology, or related field

 

Title: Scientist I-II, R&D

 

Job Description:

A motivated and independent molecular biology R&D scientist is sought to work on the development of rapid, point of care molecular nucleic acid based diagnosis kits. The ideal candidate will have demonstrated biochemistry and molecular biology expertise and experience with designing and optimizing multiplex PCR and Real Time-PCR diagnostic technology in a regulated industry environment. The successful candidate will design nucleic acid amplification primer and probes for infectious disease pathogens, develop/optimize rapid molecular diagnostic assays for human infectious diseases, integrate the developed assay chemistry to the diagnostic device, and validate the diagnostic device using well-characterized clinical samples. The experience of fluorescence-based real time PCR measurement, and handling BSL-2 and viral culture is highly desirable. The successful applicant must work within an integrated multidisciplinary laboratory and be able to work with other scientists and technicians. In addition, the scientist will be expected to interact and work effectively with a demanding, fast-paced biotech startup environment.

 

Required Skills and Experience:

  • Ph.D. in Molecular Biology, Biochemistry, or similar field with 2-5 years industry experience
  • Master’s degree in Molecular Biology, Biochemistry, or similar field with 5-7 years industry experience
  • 2-5 years’ experience designing and optimizing multiplex PCR and real-time PCR methods
  • Regulated in vitro diagnostic industry experience (ISO 13485 preferred)
  • Experience with the design control process
  • Experience with authoring SOPs, design transfer documentation, document control process, and developing quality control procedures.
  • Excellent communication skills and team-oriented

 

Desired Skills:

  • Familiarity with phylogenetic, nucleic acid primer/probe design software
  • Experience with rapid PCR methods
  • Experience with lateral flow technology
  • Enzyme kinetic and/or structural analysis is highly desirable
  • Experience with BSL-2 human pathogen handling
  • Leadership qualities and ability to mentor junior scientists

Title: Director, Quality & Regulatory Affairs

Reporting to: Chief Executive Officer

Location: San Diego, CA

Date: January 13, 2017

 

Overview: Provide direction and hands-on support for all departments in activities such as but not limited to: design control process, process development, process validation, test method validation, manufacturing, complaint handling, and regulatory submissions/compliance.  Works closely with Management to develop quality and regulatory requirements as defined by the strategy and overall direction of the company. Executes plans to ensure company meets its stated objectives. The Senior Director, Quality & Regulatory Affairs performs a variety of duties that involves company quality/regulatory business strategy, product/process development, problem solving, and developing the company Quality System and Regulatory best practices. This role will drive audit preparation for successful registration and certification as well as continual compliance to FDA Regulations and ISO 13485 Standards and serve as the Quality System Management Representative.

 

Duties (up to 10):

  • Develop, implement and maintain the company Quality System to comply with the FDA’s QSR, and ISO 13485 Standards
  • Serve as the Quality System Management Representative and primary contact for FDA, Notified Body, and other agencies as required
  • Lead the periodic Senior Management Reviews of the Quality System
  • Serve as Quality/Regulatory Chair/lead of Change Control, Material Review Board, Validations, Corrective/Preventative Actions, Continuous Improvement, Complaint Handling, and Post Market monitoring activities
  • Perform and/or support regulatory activities such as, but not limited to: submissions, clinical trials, document reviews, agency reporting, MDR reviews and reports, registration renewals and maintenance, recalls and/or field actions, etc.
  • Drive the internal and supplier audit programs, including performing or assisting with the audits
  • Establish, build and maintain professional working relationships with all levels of staff, distributors, customers, suppliers, and government agencies
  • Support Product and Process Development process for new products, product changes and enhancements
  • Drive compliance throughout the organization to policies, procedures, objectives, safety and environmental standards
  • Other duties as assigned; as emerging growth company it may be required from time to time to assist in other areas other than the area of specialty

 

Skills (up to 10):

  • Commercialization of at least two point-of-care, in-vitro diagnostic platforms
  • Experience with the development of point-of-care, in-vitro diagnostic platforms that address FDA’s Quality System Regulation and ISO 13485 design control requirements
  • Experience with managing quality system processes such as Management Review, Change Orders, Non-Conforming Materials (MRB), and Corrective/Preventive Actions (CAPA)
  • Experience driving company goals and objectives, policies and procedures, compliance to FDA regulations and ISO standards throughout an organization
  • Experience making sound decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment
  • Experience resolving issues and overcoming obstacles to assure successful outcomes; uses independent judgment to resolve unique challenges that arise periodically
  • Experience managing multiple activities and priorities concurrently to accomplish a goal; uses resources effectively and efficiently
  • Experience driving self and others to meet expectations and requirements of internal and external customers
  • Excellent interpersonal, verbal and written communication skills, meticulous attention to detail and meeting deadlines
  • Self-starter with a can-do attitude to drive quality and regulatory excellence in a fast-paced regulated start up environment

 

Requirements: 

  • Strong knowledge of the FDA QSR and ISO 13485 as well as the point-of-care, in-vitro diagnostic. Knowledge of other country directives and regulations is highly preferred
  • Prior experience in the Medical Device and/or IVD industry with early stage (Start–up) company experience highly preferred
  • Experience in leading FDA and Notified Body Audits
  • Experience leading or assisting with 510(k) or PMA submissions
  • Experience with complaint handling, review for reportability, and submitting MDR/Vigilance reports
  • Design control experience with 510k and/or PMA IVD/POC products
  • Must possess excellent written and verbal communication skills
  • Working knowledge of inspection tools such as: calipers, micrometers, snap gage, microscope, tensile tester, VIS and pin gages.
  • Product manufacturing, inspection, and testing experience
  • Experience with medical device and/or IVD manufacturing process validations using the IQ/OQ/PQ format
  • Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs
  • Knowledge of Solidworks is a plus 

 

Education: 

  • A minimum of a BS or BA in Engineering, Biology, Chemistry or equivalent and relevant industry experience
  • Minimum 10 years’ experience implementing and maintaining medical device quality systems and driving process improvements during the development, manufacture, and commercialization of point-of-care, in-vitro diagnostic platforms
  • Minimum 10 years’ experience managing Regulatory Affairs with responsibility for FDA submissions, registrations, complaint review for reportability, and generating/submitting agency reports (i.e., MDRs, Vigilance, etc.)

 

Devices and tests are currently investigational and not available for commercial sale.

Our Technology

Mesa Biotech's unique patented and patent-pending technology amplifies, labels and provides a visual qualitative result in a low-cost, disposable cassette in 30 minutes or less. This revolutionary technology offers the simplicity, convenience and procedural familiarity of traditional POC rapid immuno-assays while providing the superior sensitivity, specificity and information content of laboratory-based molecular testing.
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